Medical Devices
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IDE Guidance
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Clinical Trials and IDE Guidance Documents
A Device Clinical Trials Data Bank - Public Health Need and Impact on Industry Acceptance of Foreign Clinical Studies Bioresearch Monitoring Agreement for PMAs and PDPs - February 23, 1998 Center for Devices and Radiological Health's Investigational Device Exemption (IDE) Refuse to Accept Policy (PDF Only) (PDF - 349KB)Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff Computerized Systems Used in Clinical Trials Continued Access to Investigational Devices During PMA Preparation and Review July 15, 1996 (Blue Book Memo) (D96-1) (Text Only) Guidance for Industry and FDA Staff - In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions Draft Guidance for Industry and FDA Staff: Investigational Device Exemption (IDE) Guidance for Retinal Prostheses Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff Certification: Financial Interest and Arrangements of Clinical Investigator (PDF - 384KB)Disclosure: Financial Interest and Arrangements of Clinical Investigators (PDF - 400KB)Suggested Format For IDE Progress Report (Text Only) Goals and Initiatives for the IDE Program #D95-1 (blue book memo) (Text Only) Guidance for Industry and/or FDA Staff: Guidance Document for the Preparation of IDEs for Spinal Systems Financial Disclosure by Clinical Investigators Guidance for Industry - Collection of Race and Ethnicity Data in Clinical Trials (PDF) (PDF - 68KB)Guidance for Industry and FDA Reviewers: Content of Investigational Device Exemptions for Solutions for Hypothermic Flushing, Transport and Storage of Organs for Transplantation Guidance on IDE Policies and Procedures IDE Refuse to Accept Procedures #D94-1 (blue book memo) (Text Only) Implementation of the FDA/HCFA Interagency Agreement Regarding Reimbursement Categorization of Investigational Devices, Att. A Interagency Agreement, Att. B Criteria for Catergorization of Investigational Devices, & Att. C -List #D95-2 (blue book memo) (Text Only) Information Sheet Guidance for Institutional Review Boards (IRBs), Clinical Investigators, and Sponsors Integrity of Data and Information Submitted to ODE #I91-2 (blue book memo) (Text Only) Investigators' Responsibilities For Significant Risk Device Investigations (Nov. 1995) Pre-IDE Program: Issues and Answers - March 25, 1999 (D99-1) Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects Review of IDEs for Feasibility Studies #D89-1 (blue book memo) (Text Only) Significant Risk and Nonsignificant Risk Medical Device Studies - Information Sheet (PDF - 266KB)Sponsor's Responsibilities For Significant Risk Device Investigations (Nov. 1995) Statistical Guidance for Clinical Trials of Non Diagnostic Medical Devices Suggested Content for Original IDE Application Cover Letter (Text Only) Waiver for Additional Investigational Sites
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